Job Description

Senior QA IT Specialist

A fantastic opportunity has arisen for a Senior QA IT CSV (Computer Systems Validation) Specialist. You will be part of the part of the global Digital and Data Quality (DDQ) team and report to the Associate Director of DDQ Ireland. You will ensure the integrity and compliance of our manufacturing IT systems throughout the computerized system lifecycle. This role will focus on supporting Good Manufacturing Practices (GMP) by collaborating with various stakeholders and ensuring robust IT system change control processes are in place.

What you will do:

Bring energy, knowledge, innovation, and leadership to carry out the following:

• Collaboration with Stakeholders: Work closely with System Owners, Process Owners, Data Owners, and IT Owners to assess and select computerized systems that support GMP business processes. Ensure that selected technologies meet high-level business needs and that initial project tailoring is appropriate for the complexity and risk associated with the full scope of work.
• Quality Approval: Provide independent quality approval of key qualification and validation documentation, including policies, procedures, acceptance criteria, plans, protocols, requirements, reports, and computerized system-related changes. Ensure compliance with company standards and applicable regulations throughout the computerized system lifecycle, including changes, modifications, deviations, variances, and compliance investigations.
• Operating Level Procedures: Assure that site and above-site system owners have Operating Level Procedures/Plans, approved by Quality, in place and routinely followed to maintain computerized systems in a validated status. This includes problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs, disaster recovery plans, and business continuity plans.
• Compliance Verification: Review processes and supporting documentary evidence to verify that compliance activities related to computerized systems and data integrity are in place and effective, particularly in the context of manufacturing automation and lab systems.
• Regulatory Support: Support regulatory inspection and audit activities as needed, driving the resolution of regulatory non-conformance for GMP computerized systems and data integrity.
• System Monitoring: Monitor and communicate system health, compliance, and other metrics updates to key stakeholders, ensuring that manufacturing shopfloor systems are operating effectively.
• GMP Awareness: Promote GMP awareness and a culture of continuous improvement, facilitating manufacturing process improvements, laboratory operational excellence, and validation activities.
• Representation: Represent DDQ management upon request in local site or system-specific meetings regarding computerized systems selection and/or operation.
• Training Development: Contribute to the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in the validation, maintenance, and use of computerized systems, with a strong focus on data integrity.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Bachelor’s degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences), or equivalent.
• Hands-on experience with automated systems in pharmaceutical manufacturing, IT infrastructure, or laboratory operations.
• Strong understanding of IT system change control, data integrity, and regulatory compliance.
• Demonstrated knowledge of computerized system validation and compliance principles.
• Familiarity with implementing quality systems in pharmaceutical, laboratory, or biotechnology environments.
• Strong analytical problem-solving skills for issue identification and resolution.
• Ability to listen and integrate diverse perspectives to enhance team goals.
• Timely decision-making capabilities.
• Project management skills with a sense of urgency and a track record of delivering quality results.
• Adaptability to changing priorities.

At our company, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We’re always looking to make a difference for people, patients, and communities – from Ireland to the world.

Our Commitment to Ireland:

Our Company Ireland is one of the Ireland’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic and diverse team of over 3,000 employees currently working across seven sites in Ballydine, Co Tipperary, Brinny, Co Cork, Dunboyne, Co Meath, Carlow, and Dublin, where, in addition, operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations, our Irish sites manufacture many of the company’s top products, helping save and enhance lives in over 140 countries around the world.

The Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics, and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories, and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.

As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

cGMP Regulations, Computer System Validation (CSV), Data Integrity, Deviation Management, GMP Compliance, Good Automated Manufacturing Practice (GAMP), Periodic Reviews, Pharmaceutical Manufacturing, Quality Auditing, Quality Management Standards, Quality Standards, Regulatory Compliance

Preferred Skills:

Change Controls, Continuous Improvement, Document Validation, Problem Solving, Quality Assurance (QA), Software Development Life Cycle (SDLC), Validation Activities

Job Posting End Date:

06/27/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.